ALCOA+ in practice: data integrity checks every EDC build should pass
ALCOA+ is easy to recite and harder to evidence. Here is how each principle maps to concrete EDC configuration, audit-trail behaviour and validation tests.
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Practical notes on clinical data management, CDISC, biostatistics, bioequivalence and GxP compliance. Written by our statisticians, programmers and quality team.
3 articles
A practical guide to the line between tabulation and analysis data: which variables belong in SDTM, which are derived in ADaM, and how to keep traceability intact for reviewers.
ALCOA+ is easy to recite and harder to evidence. Here is how each principle maps to concrete EDC configuration, audit-trail behaviour and validation tests.
Reference-scaled average bioequivalence lets limits widen with the reference product's own variability. A concise walkthrough of the FDA approach, the design it needs and how it differs from EMA's ABEL.
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